Canadian Immunization Research Network Education Series Case 2: All the Senior Staff are Away
- From readings and discussions, students will describe the need for active surveillance systems in reporting serious adverse events (SAEs) to maintain vaccine safety during clinical trials.
Instructions for trainees: Please read the case, questions and resources prior to the seminar.
Amy is a seasoned nurse but a new recruit in vaccine research at a children’s hospital for sick kids. It’s July, and many of the senior staff are on summer vacation. Therefore, she must cover off on many duties of others. She is working on a study for influenza vaccine in toddlers with egg allergies. The participants are between one year and three years old with a non-anaphylactic egg allergy for which they were tested with a skin test by an allergist prior to the study. Each was given graded doses. An initial dose of 10% of the vaccine was given. Then the children were observed for 30 minutes. If there was no reaction, the children were given the remaining 90% of the vaccine and again observed for 30 minutes. One of her duties is to report severe adverse events (SAEs).
As she is reviewing the vaccination reports from the nursing staff, she notes the various reactions. On the one hand, there are some mild to moderate solicited reactions: urticaria (hives), pruritus (itching and scratching), hypotension (abnormally low blood pressure), diarrhea, vomiting, agioedema (rapid swelling) of the tongue, and oculo-respiratory syndrome (with conjunctivitis and sore throat), a fever of 38.2 degrees Celsius, and respiratory wheezing. On the other hand, there are some severe unsolicited reactions: facial paralysis three weeks after the injection and hospitalization of four days for respiratory problems.
In her opinion, most of these reactions appear to be temporal and solicited such as a sore arm or low-grade fever. Since she is extremely busy, she really doesn’t have the time to complete any adverse events following immunization (AEFIs) reports. She is not even sure what is necessary to report, to whom, and why. In fact, she isn’t sure whom to contact for advice while the senior staff are away on holidays. A few of the reactions seem quite severe like Bell’s palsy or Guillain-Barré syndrome (GBS). At first, she wonders if the reports could simply wait until August when the IMPACT nurse coordinator returns. Then, she wonders if someone should be notified to investigate, stop, or intervene in the study. Finally, she is worried that she will be held responsible for the adverse events if she fails to act, or that she will be fired if the study loses funding due to her reports.
Seminar Discussion Questions:
- What are the features of the three different types of surveillance for diseases like influenza?
2. What are the barriers to reporting adverse events following immunization (AEFIs)?
3. What are the classifications for AEFIs?
4. What are mild, moderate, and severe adverse events (SAEs) to influenza vaccine? in patients with egg allergies?
5. What events should be reported?
6. During clinical trials, why is an active surveillance system necessary to monitor influenza vaccinations?
Readings and Resources:
- An online guide with sections about vaccine safety and adverse events in the Canadian Immunization Guide from the Public Health Agency of Canada (PHAC), p.59-89
- A 56-page online guide to monitoring, investigating, and reporting adverse events following immunization from the World Health Organization (WHO), p.9-18, 23-26
- A 24-page article about the evolution and types of surveillance systems from the WHO, p.294 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2486528/
- A 22-page online journal article about multi-dose graded vaccination in egg allergic children
- A web site about the Immunization Monitoring Program ACTive (IMPACT) http://www.cps.ca/English/surveillance/IMPACT/IMPACT.htm
- A 5-page article about the history and occurrence of Guillain-Barré Syndrome and correlation with influenza vaccination from the Center for Disease Control and Prevention (CDC)
- An 8-page research article about incidents of Bell’s palsy after influenza vaccination in Switzerland
Developed 2011 by: PHAC/CIHR Influenza Research Network (PCIRN)